About this Abstract |
Meeting |
MS&T24: Materials Science & Technology
|
Symposium
|
Next Generation Biomaterials
|
Presentation Title |
Advanced Harmonization Techniques For Accurate Establishment of In Vitro-In Vivo Drug Permeation Relationships from Dissolvable Microneedle Arrays and Other Complex Dermal Dosage Forms |
Author(s) |
Audra L. Stinchcomb, Bianca Reginauld, Dana Hammell |
On-Site Speaker (Planned) |
Audra L. Stinchcomb |
Abstract Scope |
Good correlation has been observed between pharmacokinetic (PK) human dermal absorption studies and in vitro permeation testing (IVPT). Due to the intrinsic variability associated with clinical PK evaluation, the prediction of in vivo exposure from in vitro absorption testing of topical semisolid, dissolving microneedle systems, and liquid dermal products has proven difficult. Since drug absorption from complex and unoccluded formulations can be significantly influenced by environmental factors such as temperature and humidity, maximal effort must be placed on the harmonization of experimental parameters between in vitro and in vivo clinic testing conditions to establish accurate in vitro/in vivo relationships (IVIVR). The goal of the studies was to investigate if increased control over experimental parameters would result in decreased inter-subject variability from common complex dermal formulations leading to acceptable IVIVR establishment. The low variability in the human PK data presents a proof-of-concept protocol design for testing of complex dermal formulations. |